The American Society for Microbiology (ASM) strongly recommends continued strong growth for the National Institutes of Health (NIH) to sustain and expand on the extraordinary progress in medical research that has been set in motion during the past 5 years as a result of the substantial increased funding provided by Congress for the nation’s biomedical research enterprise. The Administration has proposed $27.9 billion for the NIH in its FY 2004 budget request, an increase of $549 million over FY 2003 funding. The 2 percent increase is greatly inadequate and will undoubtedly decrease and slow promising areas of biomedical research. The ASM recommends that Congress approve a 10 percent increase in the FY 2004 budget for the NIH to bring the level of funding to $30 billion. A 10 percent increase for the NIH budget will improve its ability to capitalize on the substantial achievements of the past 5 years and enhance its ability to seize scientific opportunities to advance national health and security.

Fortunately, the robust levels of budgetary support for the NIH over the past 5 years have produced medical and technological advances that serve public health as well as the defense of the nation and the world. These significant benefits include discovery of the mechanisms by which anthrax toxin destroys cells, which will speed development of anthrax therapies; the finding that available doses of licensed smallpox vaccine can be “stretched” by dilution to provide protection for more people; collaborative efforts to develop a new and safer smallpox vaccine; and new anthrax vaccine candidates that will soon enter clinical trials. NIH has also been responsible for a number of improved HIV/AIDS treatments, vaccines against pneumococcal disease and hepatitis A and B, potential vaccines against the West Nile and Ebola viruses, and genomic sequencing of more than 60 medically important microbes, including the bacteria that cause tuberculosis.

Significant health challenges remain for the 21st century to find treatments and preventions for microbial threats worldwide. NIH plays a pivotal role in research efforts to combat old and new infectious diseases that undermine health and well being and cost this country more than $120 billion annually. The multiple threats of emerging, reemerging, and drug-resistant infections mandate increased biomedical research. This is underscored by the new and evolving worldwide infectious disease threat of Severe Acute Respiratory Syndrome (SARS). Scientific progress on SARS has occurred in a short period of time as the result of the efforts of CDC, WHO and NIH. To meet the challenge of SARS and other new infectious diseases that will inevitably occur in the future, significant research and research infrastructure in infectious diseases is imperative.

The ASM, representing more than 42,000 members in the microbiological sciences, is particularly concerned with the threat from infectious diseases and bioterrorism in the United States and worldwide. The proposed FY 2004 NIH budget includes $4.3 billion for the National Institute of Allergy and Infectious Diseases (NIAID), an increase of $354 million over the FY 2003 request. The NIAID supports research and training on all aspects of infectious diseases, their causative agents and transmission, host responses to infection, advanced therapeutics and vaccines, and rapid diagnostic technologies. The NIAID over the past five years has contributed greatly to U.S. public health; for example, an impressive reduction in blood-transfusion transmission of HIV and hepatitis viruses, a 70 percent reduction in AIDS-related deaths since 1995, and the near eradication of Hemophilus influenzae infections in children.

Biodefense Research

The nation looks to the NIH and to the NIAID for safe and effective countermeasures against biological agents to defend against bioterrorist attacks. This threat presents urgent challenges and new responsibilities for the biomedical community and heightens the importance of NIAID supported research on the rapid diagnosis, prevention and treatment of potential agents of bioterrorism. The ASM supports the FY 2004 NIH budget request of $1.6 billion for biodefense research resources. The NIAID has a strategic plan and research agenda for potential agents of bioterrorism, which has been developed in collaboration with experts in the scientific community. The plan builds on NIAID funded biomedical research programs that hold promise in the defense against bioterrorism and against naturally occurring deadly infectious diseases. The NIAID is mounting an historic initiative to bring the full capability of science to bear on advances in knowledge and products to counter biological pathogens. NIAID expertise used with great success against conventional disease outbreaks will significantly enhance the effort to combat bioterrorism, and vice versa. This response to bioterrorism will require a long-term dedication of financial resources and scientific talents.

In his recent State of the Union address, President Bush proposed implementing a new initiative against biological warfare, Project Bioshield. This comprehensive plan calls for a more rapid development of state-of-the-art drugs and vaccines to target biothreat agents. Project Bioshield is intended to nurture cooperation among NIAID researchers, medical experts, and private industry to form a more focused counterterrorism defense. The Secretary of Homeland Security and the Secretary of Health and Human Services will collaborate to identify the most critical research needs. The Director of NIAID will have increased authority and flexibility to award grants for the research and development of high-priority defenses such as next-generation smallpox vaccines.

Although the NIAID has always worked to protect Americans against infectious diseases, current global and domestic affairs have forced the Institute to reevaluate and refocus its considerable expertise. Its efforts against biothreat agents have been and will continue to be rooted in solid scientific evidence acquired through basic research. But the expedited translation of basic research findings into practical-use interventions has become more central to NIAID's mission. NIAID investigators will approach potential agents of bioterrorism with new, more efficient strategies, such as the development of broader-spectrum therapeutics and vaccines. More productive cooperations with biotechnology and pharmaceutical companies likewise are expected to streamline the development of countermeasures. The NIAID plan against bioterrorism comprises two complementary components: basic research on the biology of potential microbial agents and the mechanisms of host response to infections, and applied research for the development of new or improved diagnostics, vaccines, and therapeutics.

Biodefense research is the first priority for the program increases within the proposed FY 2004 budget. The NIAID is supporting more than 50 initiatives in biodefense research. In FY 2004, it expects to add 17 new and expanded initiatives, including the acquisition and storage of standardized reagents and other materials related to the study of Category A, B, and C priority pathogens, for eventual use by investigators and laboratories engaged in biodefense research. Also in FY 2004 NIAID will refocus on current immunology and genetics programs that might provide information useful against biothreat agents. This includes the Pathogen Functional Genomics Resource Center and a to-be-established Cooperative Center for Translational Research on Human Immunology. Other planned FY 2004 initiatives include developing novel therapeutic strategies for blocking the effects of the botulinum toxin.

Infectious Disease Research

Bioterrorism threats should not diminish the NIH/NIAID mission to detect, prevent and control infectious diseases. Globally, infectious diseases are the leading cause of death, killing an estimated 14.9 million per year. In the United States infectious diseases cause millions of illnesses and cost the economy billions of dollars, despite our relatively high public health standards. We cannot be complacent about infectious diseases because of the persistence or reemergence of old diseases and the emergence of new ones such as hantavirus, West Nile virus, which has spread to 39 states infecting thousands of people, Hepatitis C virus (HCV), which has infected almost 4 million people in the United States and about 9,000 people die annually from HCV, and the global threat of Severe Acute Respiratory Syndrome (SARS), that has caused in only a few months over 330 known deaths and this number is increasing daily. There also is growing evidence that infectious agents cause or contribute to many chronic diseases and cancers. Antimicrobial resistance represents a major threat to increased mortality and morbidity from untreatable disease and the risk from the spread of drug-resistant pathogens.

Infectious diseases represent a global risk for nations and individuals. There is greater risk that Americans overseas will become exposed to serious infectious diseases like SARS, and international travel can serve as a mode of disease transmission. The NIAID has a long-standing commitment to stop the principal international killers like HIV/AIDS, tuberculosis, and malaria. The heaviest medical and economic burdens from these diseases exist outside the United States, but they endanger this country as well. Of the estimated 40 million HIV-infected persons worldwide, over 70 percent live in sub-Saharan Africa. Yet the United States has its own challenges: The annual number of new cases is not declining and perhaps one-third of those living with HIV/AIDS are unaware of their infection. The NIAID has in place a global research plan against these infections that includes significant research funding inside and outside the United States and the creation of strong alliances with international health organizations. This funding continues to produce promising candidate vaccines for prevention and therapeutic intervention, as well as breakthroughs in understanding HIV biology and host immune responses. The Administration recognizes the strategic importance of halting the HIV pandemic, evidenced in its FY 2004 budget request to fund the Emergency Plan for AIDS Relief, a five-year, $15 billion initiative that triples international HIV/AIDS funding.

Tuberculosis and malaria have been health disasters for centuries of human history. The emergence of antimicrobial-resistant strains of these pathogens, aided by increased global travel and trade, have made it difficult to stop these diseases. Among the world's populations, 16.2 million currently have active tuberculosis while malaria strikes an estimated 300 to 500 million new victims each year. If governments do not learn how to better control tuberculosis, by 2020 an additional 1 billion persons worldwide will be newly infected and 35 million of those will die, according to World Health Organization estimates. The NIAID estimates that 10 to 15 million in the United States currently have tuberculosis, and the Institute invests heavily in research on diagnostics, therapeutics and vaccines. Using a newly developed strain of tuberculosis bacterium that carries a mutated gene, NIH-funded scientists in the United States and India are learning how the pathogen protects itself and how it stimulates inflammation. In FY 2002 the NIAID established the Millennium Vaccine Initiative to search for novel vaccines against tuberculosis and malaria. Although the latter disease remains relatively rare in this country, malaria around the world causes an estimated 300 to 500 million new cases and more than 1 million deaths each year. There still is no malaria vaccine, but NIAID-supported research has accelerated vaccine development.

Global events can also affect the threat from newly emerging infectious diseases, whether through travel or trade that carries pathogens from place to place. In the past few years, several frightening diseases have found their way into various human populations, including neurodegenerative disease caused by bovine spongiform encephalopathies (BSE, e.g., "mad cow disease"), West Nile virus (WNV) infection, hantavirus infection and SARS. There will certainly be more of these unexpected outbreaks, as new microorganisms evolve and old ones develop greater virulence through resistance to standard drug therapies. NIAID research encompasses these and other emerging diseases, within strategic plans designed to anticipate more mysterious infections in the future. The NIAID is supporting WNV vaccine development and participates in the Interagency Task Force on West Nile Virus established in 2002. Studies at NIAID suggest that BSE diseases may be more widespread than believed, and scientists there plan future studies to understand its transmission from animal species to humans.

New infectious diseases attract headlines, but less dramatic diseases cost excessively in lost human and economic resources. NIAID resources are also needed to address "everyday" diseases such as hepatitis, sexually transmitted diseases, and food- and water-borne illnesses. The NIAID has made significant investments to blunt the impact of these and similar diseases, which account for many millions of illnesses each year. For example, there are an estimated 15 million new U.S. cases of STDs annually. NIAID-supported researchers have, among other discoveries, recently determined that the bacterial agent of gonorrhea binds to different molecules in the male and female genital tracts. Such detailed understanding of microbial biology and pathogenesis traditionally leads to successful therapies and prevention strategies. In 2000 an estimated 2.1 million people died worldwide from diarrheal diseases, often transmitted through food and water. At NIAID, development of a vaccine against rotavirus, a major cause of diarrhea in children, is a high global health priority.

The recently released Institute of Medicine report, “Microbial Threats to Health: Emergence, Detection and Response,” reports that “Today’s outlook with regard to microbial threats to health is bleak on a number of fronts. AIDS is out of control in much of sub-Saharan Africa, India, China and elsewhere; bioterrorism has become a reality; the relentless rise of antimicrobial resistance continues….microbial threats present us with new surprises every year.” Research is the underpinning of the nation’s capacity to prevent and control infectious diseases. A strong, stable biomedical research and training infrastructure is needed to investigate the mechanisms of molecular pathogenesis, or the cause of infectious diseases, the evolution of pathogeneses, drug resistance, and disease transmission. Fundamental scientific knowledge is needed to design new vaccines, discover new classes of antimicrobial compounds and devise new preventions and treatments for infectious diseases.

The ASM urges Congress to add 10% in FY 2004 to the doubled budget of the NIH to bring the total to $30 billion. Continued, sustained investment in NIH and NIAID is critical to dramatically reduce the threat from both naturally occurring infectious diseases and intentional use of biological agents.